Mechanical Aortic and/or Mitral Valve Replacement OperationPhase 3NCT00925197
Patient International Normalised Ratio (INR) Self-Testing Program
A Phase 3 study testing INR self-testing program in people with Mechanical Aortic and/or Mitral Valve Replacement Operation, run by University Hospital, Clermont-Ferrand.
Trial summary
The aims of the study are to prove correlation between laboratory and patient self-testing (PST) measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Aortic and/or Mitral Valve Replacement Operation
- What is being tested?
- INR self-testing program
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Jan 2009
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- adults
- patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization
- oral anticoagulant treatment
- patients with social security cover
- written informed consent signed by both patient and investigator
- able to be followed up during 12 months
Who cannot join
- refusal of participation in the study
- Participation in another clinical study
- Patient is pregnant or nursing
- Life expectancy less than three months
- Contra-indication of to an A.V.K treatment
- Difficult comprehension of the French language
Show all 10Show fewer
- Patients unable to master the self-monitoring procedures
- Individuals under judicial control or enquiry
- Patients on dialysis Patients with incomplete understanding of instructions
- Blind patients and those unable to read
About this study
Official title: Patient INR Self-Testing Program Improves the Quality of Oral Anticoagulant Therapy After Mechanical Heart Valve Replacement
The aims of the study are to prove correlation between laboratory and patient self-testing (PST) measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement.
Read the detailed description
This is the first French, prospective, randomised, single centre study, comparing patient self-testing (PST) of international normalised ratio (INR), with conventional laboratory monitoring. Aims of the study are to prove correlation between laboratory and PST measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement.
Patients (206) were postoperatively, randomly, consecutively included (2004 - 2008): 103 patients in each group, with a one year follow-up. Two INR control devices were selected: Coaguchek® (Roche) and INRATIO® (Hemosense).
- Being tested
- INR self-testing program
- Keywords
- anticoagulation, fluindione, patient self-testing, coaguchek, inratio, Post operative antivitamin K therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INR self-testing programOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhagic events and thromboembolic events
Measured: after mechanical heart valve replacement
Secondary outcomes (1)
Correlation of laboratory INR and device INR control
Measured: after mechanical heart valve replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startMay 2004
- Primary completionSep 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Aortic and/or Mitral Valve Replacement OperationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Roche Diagnostics GmbH, HemoSense
- Investigators
- Kasra Azarnoush, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925197
- Sponsor's protocol ID
- CHU-0054
- Status last verified
- Jun 2009
- First submitted
- 18 Jun 2009
- Last updated
- 22 Jun 2009
- Results posted
- No
Publications
Azarnoush K, Dorigo E, Pereira B, Dauphin C, Geoffroy E, Dauphin N, D'Ostrevy N, Legault B, Camilleri L. Mid-term results of self-testing of the international normalized ratio in adults with a mechanical heart valve. Thromb Res. 2014 Feb;133(2):149-53. doi: 10.1016/j.thromres.2013.09.013. Epub 2013 Sep 16.
PubMed 24112749